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Brief Intervention for Rural Women at High Risk for HIV/HCV (WISH)

Primary Purpose

Acquired Immune Deficiency Syndrome Virus, Hepatitis C, Drug Abuse

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MI-based HIV Risk Reduction
Sponsored by
Michele Staton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Acquired Immune Deficiency Syndrome Virus focused on measuring HIV, HCV, Substance abuse, women

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • ASSIST score of 4+
  • engagement in at least one sex risk behavior in the past 3 months
  • willingness to participate in brief intervention sessions
  • no evidence of cognitive impairment
  • no evidence of active psychosis (currently experiencing hallucinations)
  • no self-reported current symptoms of physical withdrawal from a recent episode of drug use
  • incarceration period of 1 week - 3 months in order to complete intervention sessions

Exclusion Criteria:

  • ASSIST score of <4
  • no engagement in at least one sex risk behavior in the past 3 months
  • not willing to participate in brief intervention sessions
  • evidence of cognitive impairment
  • evidence of active psychosis (currently experiencing hallucinations)
  • self-reported current symptoms of physical withdrawal from a recent episode of drug use
  • incarceration period of less than 1 week or greater than 3 months in order to complete intervention sessions

Sites / Locations

  • Rural Appalachian Research Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

NIDA Standard HIV Education

MI-based HIV Risk Reduction

Arm Description

NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources

MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community.

Outcomes

Primary Outcome Measures

Number of Participants Having Unprotected Casual Sex
Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months

Secondary Outcome Measures

Number of Participants Exchanging Sex
Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months
Number of Participants Recently Receiving Physical or Behavioral Health Treatment
Is currently being treated for a physical or mental health problem OR has been in a substance use treatment program in the last 6 months

Full Information

First Posted
April 19, 2013
Last Updated
September 17, 2019
Sponsor
Michele Staton
Collaborators
National Institute on Drug Abuse (NIDA)
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1. Study Identification

Unique Protocol Identification Number
NCT01840722
Brief Title
Brief Intervention for Rural Women at High Risk for HIV/HCV
Acronym
WISH
Official Title
Brief Intervention for Rural Women at High Risk for HIV/HCV
Study Type
Interventional

2. Study Status

Record Verification Date
August 2019
Overall Recruitment Status
Completed
Study Start Date
December 2012 (Actual)
Primary Completion Date
May 2019 (Actual)
Study Completion Date
May 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Michele Staton
Collaborators
National Institute on Drug Abuse (NIDA)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The overall aim of this study is to reduce risk behaviors and increase health and behavioral health service utilization among disadvantaged, drug-using rural women at high risk for HIV and HCV. This project has potential to make a significant contribution to science by providing knowledge about the health, risk behaviors, and service utilization of a vulnerable and understudied group of women during a time of emerging and significant public health risk in a rural Appalachian setting. Successful completion of the aims of this project will advance the delivery of a low-cost, potentially high impact intervention with implications for a number of other real world settings (such as criminal justice venues) where other disadvantaged high-risk drug users can be identified and targeted for intervention.
Detailed Description
Specific Aim 1: Compare the effectiveness of an evidence-based HIV risk reduction intervention (MI-HIV) to HIV Education (NIDA Standard) in reducing sex risk behaviors, injection practices, and drug use among a culturally unique sample of disadvantaged, drug-using rural women at high-risk for HIV and HCV. This aim will be accomplished through the random selection of high-risk rural women drug users from rural jails, screening and assessment for high-risk behavior, and random assignment to the HIV-Ed or MI-HIV intervention conditions. Follow-up interviews at 3, 6, and 12 months in the community post-release will examine changes in high-risk behavior. It is expected that MI-HIV participants will report significantly greater reductions in risky injection drug use practices, other drug use, and sex risk behaviors than women who participate in the HIV-Ed condition. Specific Aim 2: Examine MI-HIV Intervention engagement as a predictor of community health and behavioral health service utilization (including drug treatment and mental health) at follow-up among disadvantaged, drug-using rural women at high risk for HIV and HCV. This aim will focus on community service utilization during the follow-up period by the intervention and education comparison group, and how health and behavioral health service utilization relates to patterns of HIV/HCV risk behavior. It is expected that MI-HIV participants will utilize more services due to increased motivation for treatment and treatment planning following the brief intervention.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acquired Immune Deficiency Syndrome Virus, Hepatitis C, Drug Abuse
Keywords
HIV, HCV, Substance abuse, women

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
400 (Actual)

8. Arms, Groups, and Interventions

Arm Title
NIDA Standard HIV Education
Arm Type
No Intervention
Arm Description
NIDA Standard HIV Education Participants in this condition will be given HIV education using NIDA standard pre and post-test counseling, HIV and HCV rapid testing, and an information packet on existing community drug abuse and HIV/HCV resources
Arm Title
MI-based HIV Risk Reduction
Arm Type
Experimental
Arm Description
MI-based HIV Risk Reduction -- In addition to what is received in the HIV-Ed group, participants in this condition will also receive a CDC evidence-based brief intervention for high-risk women focused on an individualized plan for enhancing motivation to reduce risk behaviors and to use health and behavioral health services in the community.
Intervention Type
Other
Intervention Name(s)
MI-based HIV Risk Reduction
Other Intervention Name(s)
Motivational Interviewing for HIV Risk Reduction, Portland Women's Health Program
Intervention Description
As the only MI-based intervention identified by the CDC as a best-practice model, the MI-HIV intervention has been shown to demonstrate positive outcomes for criminal justice-involved women randomly assigned to the intervention group for risky sexual activity and drug use with sustained behaviors through 9 months.
Primary Outcome Measure Information:
Title
Number of Participants Having Unprotected Casual Sex
Description
Had unprotected sex with a casual partner or when trading sex for money, drugs, etc in the past 6 months
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Number of Participants Exchanging Sex
Description
Sex with a Partner in Exchange for Money, Drugs, Food, Shelter, Transportation, etc. in the past 6 months
Time Frame
6 months
Title
Number of Participants Recently Receiving Physical or Behavioral Health Treatment
Description
Is currently being treated for a physical or mental health problem OR has been in a substance use treatment program in the last 6 months
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASSIST score of 4+ engagement in at least one sex risk behavior in the past 3 months willingness to participate in brief intervention sessions no evidence of cognitive impairment no evidence of active psychosis (currently experiencing hallucinations) no self-reported current symptoms of physical withdrawal from a recent episode of drug use incarceration period of 1 week - 3 months in order to complete intervention sessions Exclusion Criteria: ASSIST score of <4 no engagement in at least one sex risk behavior in the past 3 months not willing to participate in brief intervention sessions evidence of cognitive impairment evidence of active psychosis (currently experiencing hallucinations) self-reported current symptoms of physical withdrawal from a recent episode of drug use incarceration period of less than 1 week or greater than 3 months in order to complete intervention sessions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michele Tindall, PhD
Organizational Affiliation
University of Kentucky
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rural Appalachian Research Center
City
Hazard
State/Province
Kentucky
ZIP/Postal Code
41071
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
N/A, individual participant data will not be made available.

Learn more about this trial

Brief Intervention for Rural Women at High Risk for HIV/HCV

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